NCT00262470 — drugset

Summary

This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.

Timeline

Start: 1997-04
Primary completion: 2029-12
Completion: 2029-12

Publications

Results Raj SR, Black BK, Biaggioni I, Harris PA, Robertson D. Acetylcholinesterase inhibition improves tachycardia in postural tachycardia syndrome. Circulation. 2005 May 31;111(21):2734-40. doi: 10.1161/CIRCULATIONAHA.104.497594. Epub 2005 May 23.
Results Raj SR, Black BK, Biaggioni I, Paranjape SY, Ramirez M, Dupont WD, Robertson D. Propranolol decreases tachycardia and improves symptoms in the postural tachycardia syndrome: less is more. Circulation. 2009 Sep 1;120(9):725-34. doi: 10.1161/CIRCULATIONAHA.108.846501. Epub 2009 Aug 17.
Smith EC, Diedrich A, Raj SR, Gamboa A, Shibao CA, Black BK, Peltier A, Paranjape SY, Biaggioni I, Okamoto LE. Splanchnic Venous Compression Enhances the Effects of ss-Blockade in the Treatment of Postural Tachycardia Syndrome. J Am Heart Assoc. 2020 Jul 21;9(14):e016196. doi: 10.1161/JAHA.120.016196. Epub 2020 Jul 16.
Nwazue VC, Paranjape SY, Black BK, Biaggioni I, Diedrich A, Dupont WD, Robertson D, Raj SR. Postural tachycardia syndrome and inappropriate sinus tachycardia: role of autonomic modulation and sinus node automaticity. J Am Heart Assoc. 2014 Apr 10;3(2):e000700. doi: 10.1161/JAHA.113.000700.
Nwazue VC, Arnold AC, Raj V, Black BK, Biaggioni I, Paranjape SY, Orozco C, Dupont WD, Robertson D, Raj SR. Understanding the placebo effect in clinical trials for postural tachycardia syndrome. Clin Exp Pharmacol Physiol. 2014 May;41(5):325-30. doi: 10.1111/1440-1681.12221.
Green EA, Black BK, Biaggioni I, Paranjape SY, Bagai K, Shibao C, Okoye MC, Dupont WD, Robertson D, Raj SR. Melatonin reduces tachycardia in postural tachycardia syndrome: a randomized, crossover trial. Cardiovasc Ther. 2014 Jun;32(3):105-12. doi: 10.1111/1755-5922.12067.
Mar PL, Raj V, Black BK, Biaggioni I, Shibao CA, Paranjape SY, Dupont WD, Robertson D, Raj SR. Acute hemodynamic effects of a selective serotonin reuptake inhibitor in postural tachycardia syndrome: a randomized, crossover trial. J Psychopharmacol. 2014 Feb;28(2):155-61. doi: 10.1177/0269881113512911. Epub 2013 Nov 13.
Green EA, Raj V, Shibao CA, Biaggioni I, Black BK, Dupont WD, Robertson D, Raj SR. Effects of norepinephrine reuptake inhibition on postural tachycardia syndrome. J Am Heart Assoc. 2013 Sep 3;2(5):e000395. doi: 10.1161/JAHA.113.000395.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acetazolamide	Small molecule	250 mg	Oral
Subject	Atomoxetine	Other / unclassified	10 mg	Oral
Subject	Atomoxetine	Other / unclassified	40 mg	Oral
Subject	Clonidine	Other / unclassified	0.05 mg	Oral
Subject	Clonidine	Other / unclassified	0.3 mg	Oral
Subject	Entacapone	Small molecule	200 mg	Oral
Subject	Entacapone	Small molecule	400 mg	Oral
Subject	Indomethacin	Small molecule	25 mg	Oral
Subject	Indomethacin	Small molecule	50 mg	Oral
Subject	Isosorbide Dinitrate	Other / unclassified	5 mg	Oral
Subject	Isosorbide Dinitrate	Other / unclassified	20 mg	Oral
Subject	Mecamylamine	Small molecule	1.25 mg	Oral
Subject	Mecamylamine	Small molecule	5 mg	Oral
Subject	Melatonin	Small molecule	3 mg	Oral
Subject	Memantine	Unknown	5 mg	Oral
Subject	Memantine	Unknown	20 mg	Oral
Subject	Midodrine	Small molecule	2.5 mg	Oral
Subject	Midodrine	Small molecule	10 mg	Oral
Subject	Modafinil	Small molecule	100 mg	Oral
Subject	Modafinil	Small molecule	200 mg	Oral
Subject	Octreotide	Peptide	12.5 ug	Subcutaneous
Subject	Octreotide	Peptide	50 ug	Subcutaneous
Subject	Propranolol	Small molecule	10 mg	Oral
Subject	Propranolol	Small molecule	20 mg	Oral
Subject	Propranolol	Small molecule	80 mg	Oral
Subject	Sertraline	Small molecule	25 mg	Oral
Subject	Sertraline	Small molecule	50 mg	Oral

Treatment of Orthostatic Intolerance

Summary

Timeline

Publications

Drugs

Indications